Frequently Asked Questions

What is the IRB?

The Institutional Review Board (IRB) is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.

What are the types of IRB reviews

Exempt Review - Research is no more than minimal risk to human subjects as determined by regulatory guidelines. Maybe be granted by the IRB upon review of the application.

Expedited Review - Research only involves no more than a minimal risk to human subjects, including blood sampling in minimal amounts, review of records collected for non-research purposes, and survey research.

Full Board Review - Research involving greater than minimal risk, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk.

As a student how do I submit an IRB

ALL students must contact their faculty advisors before they can submit an IRB.

What is human subjects training

All Investigators, Co-Investigators, and key personnel must complete human subjects training before submitting an IRB application. Lamar University uses CITI (Collaborative Institutional Training Initiative) for Basic Human Subjects Research (BHSR) training. Registration for these courses is available through CITI.

I am doing a survey do I need an IRB

Yes, if the study meets the definition for research with human subjects, Lamar University's Federalwide Assurance (FWA) with the Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Approval from the IRB must be in place before any interventions or interactions with human subjects can actually begin.

What is a consent form?

A consent form is a written document that explains the research study to potential study participants. This document is signed by the study participants and must contain information / statements to ensure that subjects are fully informed about the study. If you are a student, then please contact your faculty advisor for specific required document information.

How long does approval take for an IRB

Various factors influence the length of time necessary to approve an IRB submission, including the quality of the application, current volume of applications submitted and under review, and the type of review. The approval process also depends on the type of review submitted. Exempt and Expedited submissions are approved fairly quickly but Full Board submissions may take longer.

Common reasons for delayed approval

Human Subjects training is not current.

Plan for protecting privacy of participants and maintaining confidentiality of their data is inadequate.

Consent documents lack required elements.

Missing or incomplete responses on submission.

Information on the submission and/or consent form is inconsistent.

Insufficient detail in description of procedures.

Misunderstanding of eligibility for exempt status.

What do to if IRB approval has lapsed

If the approved IRB has expired a new IRB must be submitted and approved. If the IRB has not approved the renewal of a research study by the end of the original one year approval period, all research activities must cease, including recruitment and enrollment of subjects, consent, interventions, interactions, and data collection until renewal approval has been received.

Where can I receive help using LU Cayuse IRB?

For help using the LU Cayuse IRB online submission platform, go to IRB Help.